Patient Reported Outcomes also referred to is PRO has been an umbrella term in the healthcare industry for a long time now, Patient reported outcomes is used to refer to patient satisfaction, productivity assessments, and anything that involves patient reporting. Because of this, the definition (which very many definitions exists) of patient reported outcomes is quite broad. One of the more common definitions of patient reported outcomes was that made byICHOM’s. Their definition is based on Wilson and Cleary’s work, which divides patient reported outcomes into three main categories:
- Symptom burden
- Functional impact
- Health-related quality of life
A good definition of patient reported outcomes should be clear and specific and should distinguish between measures of patients’ health versus the experience of their care. Searching methods for patient reported outcomes are the same as for other outcomes . Usually all reports retrieved by the review’s search strategy will be examined to identify those that include the patient reported outcomes of interest. Sometimes a separate, additional, patient reported outcomes search might be used to supplement the standard strategy. For example, if a review of randomized trials and other studies in the area of asthma did not yield studies using patient reported outcomes, a separate search could be performed to include search terms specific to patient reported outcomes used in asthma, such as ‘asthma-specific quality of life’. However, this relies on there being mention of the patient reported outcomes in the electronic record within the databases searched.
Below are some basic points about Patient Reported Outcomes –
- An outcome is a result or end state; anything measuring an intermediate state isn’t an outcome.
- Patient-reported outcomes (PROs) are reports coming directly from patients about how they feel or function in relation to a health condition and its therapy without interpretation by healthcare professionals or anyone else.
- PROs can relate to symptoms, signs, functional status, perceptions, or other aspects such as convenience and tolerability.
- Items reflecting the concepts included in a PRO questionnaire are elicited from the target population; patient involvement in questionnaire generation is essential for content validity.
- A glossary is provided on the PRO Methods Group web site (www.cochrane-pro-mg.org) for finding definitions of terms unfamiliar to authors.
- PROs are not only important when more objective measures of disease outcome are not available but also to represent what is most important to patients about a condition and its treatment.
- PROs can be continuous or categorical. Techniques are available to pool both kinds of measures.
- Review authors may need to do background reading about PROs to ensure they understand those chosen for inclusion into trials, in particular their validity and ability to detect change.
- A checklist is provided in this chapter on issues relating to PROs that authors should consider before incorporating PROs into their reviews and ‘Summary of findings’ tables.
- If completed reviews fail to record PROs when they were chosen as important outcomes in the review protocol, then they should be highlighted in the review as a deficiency in the current research on efficacy of treatment.
FAQs About Patient Reported Outcomes
- What were PROs measuring?
- What rationale (if any) for selection of concepts or constructs did the authors provide?
- Were patients involved in the selection of outcomes measured by the PROs?
- Were there any important aspects of health (e.g., symptoms, function, perceptions) or quality of life (e.g. overall evaluation, satisfaction with life) that were omitted in this study from the perspectives of the patient, clinician, significant others, payers, or other administrators and decision makers?
- If randomized trials and other studies measured PROs, what were the instruments’ measurement strategies?
- Did investigators use instruments that yield a single indicator or index number, a profile, or a battery of instruments?
- If investigators measure PROs, did they use specific or generic measures, or both?
- Who exactly completed the instruments?
- Did the instruments work in the way they were supposed to work – validity?
- Had the instruments used been validated previously (provide reference)? Was evidence of prior validation for use in this population presented?
- Were the instruments re-validated in this study?
- Did the instruments work in the way they were supposed to work – ability to measure change?
- Are the PROs able to detect change in patient status, even if those changes are small?
- Can you make the magnitude of effect understandable to readers?
- Can you provide an estimate of the difference in patients achieving a threshold of function or improvement, and the associated number needed to treat (NNT)?
- What is the rationale for collecting patient-reported outcome information?
- What mechanisms are used internationally for the routine collection and aggregation of patient-reported outcome information at national or state/province level, and are there particular patient-reported outcome measures and conditions which are more commonly aggregated and reported at this level?
- What are the reported uses of patient-reported outcome information in terms of quality and safety improvement?
- What have been the reported impacts, benefits and challenges of collection of patient-reported outcome information at national or state/province level?